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Trial record 12 of 34 for:    "Collagen Disease" | "Tranexamic Acid"

Intra-articular Tranexamic Acid in the Reduction of Blood Transfusions in Primary Total Hip and Total Knee Arthroplasty

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ClinicalTrials.gov Identifier: NCT02393963
Recruitment Status : Completed
First Posted : March 20, 2015
Last Update Posted : April 10, 2017
Sponsor:
Information provided by (Responsible Party):
Orthopaedic Innovation Centre

Brief Summary:
This is a randomized, double blinded, controlled trial in patients undergoing elective Total Knee Arthroplasty (TKA) and Total Hip Arthroplasty (THA). The study group will receive intra-articular Tranexamic Acid (TXA) while the control group will receive normal saline placebo.

Condition or disease Intervention/treatment Phase
Osteoarthritis Drug: Tranexamic Acid Other: Placebo Phase 2

Detailed Description:
The primary purpose of this study is to determine if intra-articular administration of low dose TXA following THA and TKA results in a clinically relevant reduction in blood loss. The secondary purpose is to determine if there is an increased risk of thromboembolic phenomena with the use of TXA following elective THA and TKA. The primary outcome metric will be - drop in hemoglobin following surgery; secondary metrics include blood loss, transfusion rate, d-dimers, troponin levels, symptomatic deep venous thrombosis (DVT) and pulmonary embolism (PE), vascular events (myocardial infarction, stroke), major and minor bleeding, and death.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Official Title: Role of Low Dose Intra-articular Tranexamic Acid in the Reduction of Blood Transfusions in Primary Total Hip and Total Knee Arthroplasty: A Randomized Placebo Controlled Study
Actual Study Start Date : July 2015
Actual Primary Completion Date : July 2016
Actual Study Completion Date : December 21, 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Tranexamic Acid
Intra-articular administration of low dose Tranexamic acid
Drug: Tranexamic Acid
0.5g Tranexamic Acid in 0.9% Sodium Chloride (study group) will be injected into the joint after final closure through a temporary catheter that is brought out through the incision.
Other Name: DIN#: 02246365, Sandoz Canada Inc.

Placebo Comparator: Placebo
Sodium Chloride
Other: Placebo
0.9% Sodium Chloride (placebo group) will be injected into the joint after final closure through a temporary catheter that is brought out through the incision.
Other Name: Sodium Chloride solution




Primary Outcome Measures :
  1. Change from Baseline in hemoglobin during hospital stay [ Time Frame: routinely measured post-op day 1 and 3 ]

Secondary Outcome Measures :
  1. Serum Troponin [ Time Frame: Every 6 hours for 24 hours post-op ]
  2. D-dimer [ Time Frame: Post-op day 1 and 2 ]

Other Outcome Measures:
  1. Post-operative blood transfusion [ Time Frame: During the first 7 days ]
    documentation of blood transfusion post-operative

  2. Major or minor bleeding events [ Time Frame: within 90 days of surgery ]
  3. Self-reported visual disturbances [ Time Frame: within 90 days of surgery ]
  4. Self-reported symptomatic DVT [ Time Frame: within 90 days of surgery ]
  5. Self-reported PE [ Time Frame: within 90 days of surgery ]
  6. Self-reported stroke [ Time Frame: within 90 days of surgery ]
  7. Death [ Time Frame: within 90 days of surgery ]
  8. Intra-operative fluid balance [ Time Frame: during surgery ]
    documentation of the volume of saline fluid via intravenous given to patients

  9. Bleeding sources other than the knee or hip (eg: GI bleed) [ Time Frame: within 90 days of surgery ]
  10. post-operative fluid balance [ Time Frame: within 3- 5 days of surgery ]
    documentation of the volume of saline fluid via intravenous given to patients



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • with osteoarthritis
  • scheduled for elective primary unilateral THR or TKR
  • provided informed consent
  • can read, write and speak English

Exclusion Criteria:

  • history of arterial or venous thromboembolic disease (myocardial infarction, symptomatic ischemic heart disease, atrial fibrillation, cerebrovascular accident, deep-vein thrombosis, pulmonary embolus, or thrombogenic cardiac valvular disease or rhythm disease)
  • pre-operative Hg of <120 g/L
  • Known allergy to Tranexamic Acid
  • Coagulation disorder
  • Acquired disturbances of color vision
  • Hepatic insufficiency, any history of liver disease
  • Renal insufficiency (on dialysis)
  • Preoperative prophylactic use of antiplatelet or anticoagulant therapy such as Clopidogrel, Warfarin, dabigatran or Rivaroxaban. This does not include low dose Aspirin (81mg)
  • Patients with a history of subarachnoid hemorrhage [20]
  • Simultaneous bilateral THA or TKA
  • Any contra-indication for spinal anesthesia
  • Allergy to Celecoxib, which will be the only nonsteroidal anti-inflammatory drugs (NSAID) used in the multi-modal analgesia regime.
  • Retinal vein or retinal artery occlusion
  • Female on oral contraceptive pills and/or premenopausal
  • Concurrently taking hydrochlorothiazide, desmopressin, sulbactam-ampicillin, carbazochrome, ranitidine and/or nitroglycerin for the duration of the surgery.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02393963


Locations
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Canada, Manitoba
Concordia Hospital
Winnipeg, Manitoba, Canada, R2K 3S8
Sponsors and Collaborators
Orthopaedic Innovation Centre
Investigators
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Principal Investigator: Thomas R Turgeon, MD Concordia Joint Replacement Group

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Responsible Party: Orthopaedic Innovation Centre
ClinicalTrials.gov Identifier: NCT02393963     History of Changes
Other Study ID Numbers: B2013-089
First Posted: March 20, 2015    Key Record Dates
Last Update Posted: April 10, 2017
Last Verified: September 2016

Additional relevant MeSH terms:
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Rheumatic Diseases
Tranexamic Acid
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Hemostatics
Coagulants